The purpose of this study is to determine the impact of a 12-week aerobic and resistance exercise training program on mental health and CD4 counts among female HIV+ patients.
Thirty HIV+ women with age range 20-40 years ( inclusion criteria) without any implications for Diagnoses of any other current opportunistic infection (exclusion criteria) , will select voluntarily among 240 HIV+ female patients referring to Voluntary counseling Counseling and treatment Treatment Center (VCT) and randomly will be divided into two control (n = 15) and experimental group (n = 15).
After providing informed consent, all participants will complete the GHQ28 questionnaire in order to assess their mental health status and the blood samples will also be collected to measure the CD4+ T cell count before and after the intervention. The experimental group will participate in a 12 (3 day/week) week supervised combined aerobic and resistance exercise program. Two groups will be compared after interventions.The researchers hypothesize that the experimental group, compared to the study controls, would have improved in CD4 counts and mental health after interventional program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020220910N1
Registration date:2015-02-28, 1393/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-28, 1393/12/09
Registrant information
Name
Mohammad Ali Davarpanah
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3738 6272
Email address
davarpanah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks combination exercises on Mental Health and CD4 count in HIV+ women in Shiraz
Public title
The effect of exercises on Mental Health and CD4 count
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: All women diagnosed with HIV infection with CD4+ T cell count ≥350 cells/mm3; age range between 20-40 years.
Exclusion Criteria: Entry to AIDS step; implications for Diagnoses of any other current opportunistic infection such as TB; pregnancy and suffering from severe symptoms which made it difficult for them to do the exercises.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Shiraz University of Medical Sciences
Street address
7th Floor,Central Building, Shiraz University of Medical Sciences, Zand Ave, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
C-T-P-93/78-7258
Health conditions studied
1
Description of health condition studied
Mental Health
ICD-10 code
zo4.8
ICD-10 code description
Examination and observation for other specified reasons
Primary outcomes
1
Description
CD4 General Health
Timepoint
3 Months
Method of measurement
Questionary Sample
Secondary outcomes
1
Description
BMI
Timepoint
3 Months
Method of measurement
BMI Instrument
Intervention groups
1
Description
Control group will receive no exercise during 3 mounts.
Category
Other
2
Description
The intervention group will participate in a 12 (3 day/week) week supervised combined aerobic and resistance exercise program. The exercise group trained for 90 min/day. The program was comprised of warm-up (20 min), combined exercises (60 min), and cool down for 10 min.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Voluntary Counseling and Treatment Center( VCT)
Full name of responsible person
Mahmood AminiLari
Street address
Voluntary Counseling and Testing Center, Lavan Ave,Delavaran-e Basij Blvd,Khatoun Sq, Shiraz, Fars, Iran Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr.Poostfroosh
Street address
2nd floor,Voluntary Counseling and Testing Center, Lavan Ave,Delavaran-e Basij Blvd,Khatoun Sq, Shiraz, Fars, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz HIV/ AIDS Research Center, Shiraz University of Medical Science
Full name of responsible person
Mahmood AminiLari
Position
Executive Director/ MA
Other areas of specialty/work
Street address
2nd floor,Voluntary Counseling and Testing Center, Lavan Ave,Delavaran-e Basij Blvd,Khatoun Sq, Shiraz, Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
maminil@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz HIV/AIDS Research Center, Shiraz University of Medical Sciences
Full name of responsible person
MohammadAli Davarpanah
Position
Infectious disease
Other areas of specialty/work
Street address
2nd floor,Voluntary Counseling and Testing Center, Lavan Ave,Delavaran-e Basij Blvd,Khatoun Sq, Shiraz, Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
davarpanah@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz HIV/AIDS Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Mahmood AminiLari
Position
Executive Director / MA
Other areas of specialty/work
Street address
2nd floor,Voluntary Counseling and Testing Center, Lavan Ave,Delavaran-e Basij Blvd,Khatoun Sq, Shiraz, Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
+98 71 3738 6272
Email
maminil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)